Business Context and Reporting Period
Company: InspireMD, Inc. (NSPR)
Filing Type: Form 8-K (Current Report)
Date of Report: June 11, 2026
Reporting Period: Single event date (June 11, 2026)
Business Context: The filing discloses a material event under Regulation FD regarding the announcement of 30-day results from the CGUARDIANS II Clinical Trial for the CGuard Prime 80 cm Implant, intended for use in Transcarotid Artery Revascularization (TCAR) procedures.
Key Financial Metrics
This Form 8-K is a disclosure of a specific corporate event and does not contain financial statements. Consequently, the filing text does not provide clear values for revenue, profit, cash flow, margins, debt, or liquidity metrics.
Material Changes
The material change reported is the release of clinical trial data. The Company announced 30-day results from the CGUARDIANS II Clinical Trial concerning the CGuard Prime 80 cm Implant. No financial performance changes versus prior periods are detailed in this document.
Guidance, Outlook, and Risks
Management Commentary: The filing incorporates by reference a press release (Exhibit 99.1) detailing the clinical trial results. The specific outcomes of the trial are not summarized within the body of the 8-K text itself.
Legal Disclaimer: In accordance with General Instruction B.2 of Form 8-K, the information furnished under Item 7.01 (including the press release) is not deemed "filed" for purposes of Section 18 of the Exchange Act and is not subject to the liabilities of that section, nor is it incorporated by reference into other filings unless expressly stated.
Investor Verification Checklist
- Review Exhibit 99.1 (Press Release) for the specific 30-day clinical outcomes of the CGUARDIANS II trial.
- Verify the regulatory implications of the CGuard Prime 80 cm Implant results for future TCAR procedure approvals.
- Check subsequent filings (e.g., 10-Q or 10-K) for any financial impact resulting from this clinical milestone.
- Confirm the trading status of NSPR on The Nasdaq Capital Market following the announcement.